Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer

NCT ID: NCT03939156

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-05
• Study Completion Date: 2023-12-31

Brief Summary

Preference studies reveal how individuals trade-off the potential benefits, harms and inconveniences of a treatment by determining the minimum benefits they judge sufficient to make the treatment worthwhile.

They are especially relevant to adjuvant therapies where individuals must weigh up modest survival benefits only realized in time by no recurrence of their cancer with side effects predominantly experienced whilst on the treatment.

Previously it was reported, for example, that over 50% of women who had adjuvant chemotherapy for early breast cancer judged a 1% improvement in 5 year survival rates sufficient to make it worthwhile.

Larger survival benefits were required for longer duration adjuvant hormonal therapy where over 50% of women required at least 5% improvement in 5 year survival rates to make it worthwhile.

Detailed Description

The endocrine therapy is generally proposed to all patients with endocrine positive early breast cancer to reduce the risk of recurrence and death. Moreover several data support that the prolongation of hormonal therapy (i.e. 10 years of hormonal treatment) is associated with statistical improved outcome.

In order to achieve the benefit related to hormonal therapy all women have to be treated despite the fact that the data and analyses are unable to differentiate as to whether a small prolongation in survival accrues to all women treated or a few patients survive who would otherwise have died. Moreover the hormonal therapy is associated with side effects that may impact the quality of life of the patients.

Patients are more likely to accept treatment on the basis of presented relative rather than absolute risks and so the question arises as to whether unrealistic improvements in outcome are expected by patients.

The interviews with patients in the proposed trial will elicit the expected gains both in terms of survival and life years and will be able to assess the proportion of patients who considered an improvement of realistic size was sufficient to justify the treatment and the prolongation of the treatment.

Several studies showed that choices are guided by the personal attitude to react and adapt to traumatic events, individual resilience.

It is important therefore to consider also the influence of these factors on the patients' treatment preferences.

For this reason, besides the elicitation of preferences, resilience and reaction to traumatic events will be assessed thorough validated questionnaires.

Conditions

Breast Cancer; Endocrine Breast Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1 - before starting ET

women candidate to receive ET and interviewed before starting treatment

Completion of questionnaires

Intervention Type: OTHER

Completion of questionnaires at the time of study entry

Group 2 - within 1 year of ET

women interviewed within 1 years from beginning of ET

Completion of questionnaires

Intervention Type: OTHER

Completion of questionnaires at the time of study entry

Group 3 - between 4 and 6 years of ET

women interviewed after more than 4 years but no more than 6 years of ET

Completion of questionnaires

Intervention Type: OTHER

Completion of questionnaires at the time of study entry

Interventions

Completion of questionnaires

Completion of questionnaires at the time of study entry

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women candidate to adjuvant hormonal therapy for breast cancer before the start of therapy
• Women who are receiving hormonal therapy (within 1 year from beginning)
• Women who are receiving hormonal therapy (who had receive at least 4 or 5 or 6 years of hormonal therapy)
• Patients who underwent to radical surgery for breast cancer
• Patients who have received neoadjuvant or adjuvant chemotherapy are also eligible
• Hormonal receptors positive breast cancer (ER and or PgR >1%)
• Sufficient literacy in Italian to complete the questionnaires.

Exclusion Criteria

• Patients who had received at least 1 year and no more than 3 years of hormonal therapy
• Patients who are receiving hormonal therapy (who had receive 7 years or more of hormonal therapy)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilia Montagna, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

European Institute of Oncology

Milan, , Italy

Countries

Italy

Other Identifiers

IEO 0837/

Identifier Type: -

Identifier Source: org_study_id